Phase 2b Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: 1,3-dipropyl-8-(2-(5,6-epoxy)norbornyl)xanthine

Criteria

Inclusion Criteria:

• Previous diagnosis of heart failure.

• Must have ADHF, requiring hospitalization, with clinical evidence for volume overload

Exclusion Criteria:

• History of an allergic reaction to any xanthine-containing substance.

• History of seizure

• History of stroke

• Myocardial infarction

• Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.

• Serious systemic infection

• Major surgical procedures within 30 days

• Acute coronary syndrome

• Cardiogenic shock

• Baseline body weight >150 kg

• Participation in any other investigational study of drugs or devices within 30 days prior to Screening

• Nursing mothers, pregnant women, or women planning on becoming pregnant during the study

• Presence of any clinically significant condition that might interfere with optimal safe participation in this study